In a copending U.S. patent application Ser. No. 07/846,322, filed on Mar. 5, 1992, entitled Hemostatic Puncture Closure System and Method of Use, which is a Continuation-In-Part of a copending United States patent application Ser. No. 07/798,704, filed on Nov. 8, 1991, and of the same title, both of which are assigned to the same assignee as this invention, and whose disclosures are incorporated by reference herein, there are disclosed systems for sealing a percutaneous incision or puncture in a blood vessel. Those systems basically comprise a closure, an introducer, and a deployment instrument including a carrier for the closure.
The closure has three basic components, namely, a sealing member, an intraarterial anchor member, and a positioning member. The sealing member is in the form of an elongated rod-like plug, e.g., a compressed hemostatic, resorbable collagen sponge or foam. This plug member is arranged for sealing the puncture. The anchor member is an elongated, stiff, low-profile member which is arranged to be seated inside the artery against the artery wall contiguous with the puncture. The anchor member is molded of non-hemostatic resorbable polymer similar to resorbable suture. The positioning member comprises a filament, e.g., a resorbable suture. The filament connects the anchor member and the collagen plug (sealing member) via a pulley-like arrangement which serves to move the plug toward the anchor member by pulling on the filament when that member is located within the interior of the artery and in engagement with the inner wall of the artery contiguous with the incision or puncture. A tamping member, forming a portion of the deployment instrument is provided to tamp the plug within the puncture tract. This action causes the plug to deform into a larger diameter body. Expansion of the plug is enhanced by the fact that it is formed of a compressed collagen so that it expands in the presence of blood within the puncture tract. The expansion of the plug within the puncture tract serves to hold it in place. The closure quickly becomes locked in place through the clotting of the hemostatic collagen plug within the puncture tract, and by tension applied to the filament via spring means forming a portion of the deployment system.
In another copending U.S. patent application Ser. No. 08/012,816, filed on Feb. 3, 1993, entitled A Hemostatic Vessel Puncture Closure System Utilizing A Plug Located Within The Puncture Tract Spaced From The Vessel, And Method of Use, which is assigned to the same assignee as this invention, and whose disclosure is incorporated by reference herein, there is disclosed a system for sealing a percutaneous incision or puncture in a blood vessel or other lumen. That system includes a closure, similar in most respects to the closures disclosed in the above mentioned copending application but also having means for preventing the sealing portion of the closure from gaining access into the interior of the artery. In particular, the application Ser. No. 08/012,816 discloses a closure including a spacer member interposed between the anchor member and the plug member to keep the plug member in the puncture tract but spaced from the opening in the artery.
In some cases during deployment of a closure having an anchor like those of the above described systems, the anchor may break apart due to a material defect or a fault in the molding of the anchor. Such action may result in a portion of the anchor member becoming dislodged and being carried by the blood to some remote location within the patient's body, thereby posing a medical hazard.
The reinforcement of resorbable devices to increase their strength has been disclosed in U.S. Letters Pat. No. 4,743,257 (Tormala et al.). In particular that patent discloses surgical osteosynthesis devices or their component plates, pins, nails, medullary rods, screws, or corresponding structures formed of a resorbable polymer or copolymer matrix reinforced with resorbable reinforcement units of the same chemical element percentage composition as the matrix itself to increase the strength of the devices. There is no disclosure nor suggestion of some reinforcement means to hold pieces of an anchor of an arterial closure together should to prevent it from break apart and separating from other parts of the closure during a deployment operation.
Accordingly, the need exists for a vascular closure device having an anchor which is reinforced to preclude it from accidentally breaking apart and separating from the rest of the closure during its deployment or thereafter. A need also exists for a vascular closure including an anchor which is sufficiently reinforced so that if during the closure deployment procedure the physician is not satisfied with the placement of the anchor within the vessel and he/she decides to remove it, such action can be accomplished by pulling on the filament to cause the anchor to deform so that it can pass back out through the incision or puncture without any portion breaking away from the closure.